FEATURED EDITORIAL
Peptides are an important class of molecules placed between small molecules and biomolecules. Synthetic peptide-related impurities can originate from raw materials, manufacturing processes, degradation, and other causes. This article shares perspectives and recommendations discussed at USP's recent 2022 workshop on the topic.
- Tools & Techniques For Biopharma Root Cause Analysis
- The Promising Emergence Of Venom-Derived Compounds
- What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I
- The Promise Of Gene Silencing: A Primer On siRNA
- Your 3-Step Process For Innovation In Precision Medicine
- No Matter Modality, A Methodology For Managing CDMOs
- Venture Philanthropy For Duchenne Muscular Dystrophy
GUEST COLUMNISTS
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The Promising Emergence Of Venom-Derived Compounds
There are 100,000+ venomous animal species, each producing a chemical cocktail of up to 1,000 different components, including peptides, proteins, and non-peptide small molecules. Many in drug development view venom-derived compounds as simple peptides that will be easily digested, limiting their therapeutic potential. This article dispels that myth.
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What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I
One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.
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The Promise Of Gene Silencing: A Primer On siRNA
Small interfering RNAs (siRNAs) are short sequences of RNA that interfere with gene expression, reducing or eliminating the expression of a disease-related protein by targeting its corresponding mRNA. siRNAs could treat a wide array of diseases. How does it differ from other therapeutic modalities such as gene therapy and gene editing?
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Your 3-Step Process For Innovation In Precision Medicine
Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts?
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Venture Philanthropy For Duchenne Muscular Dystrophy
This article reviews a number of these advancements and how diseased-focused venture investing can help drive development of next generation therapies.
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Your Guide To Producing ADCs That Meet cGMP Expectations
Antibody-drug conjugates (ADCs) are a diverse class of biopharmaceuticals that combine highly selective monoclonal antibodies specific to surface antigens present on particular tumor cells. Discussion of current good manufacturing practices (cGMP) in this article includes containment, cleaning and decontamination, and manufacturing and purification.
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Data: The Near Future Of Regulatory Info Management In Europe
Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.
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Heightened Standards For Satisfying Written Description In Pharma Patents
In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.
PHARMA OUTSOURCING WHITE PAPERS
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Bulletproof Supply Chain: Hope For The Best, Prepare For The Worst
How to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how a risk-based approach can determine where a contingency plan is needed.
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CDMO Collaboration: Foundation For Sterile Injectable Product Success
Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.
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Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations
Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.
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Pediatric Dosage Forms: Reformulation And Development Expertise
Infrastructure and expertise cover the sweet spot for producing the small-to-midsize batches needed to meet industry demands for PDFs and orphan drugs, and also extend to large-scale manufacturing.
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Rational Design & Development Of Long-Acting Injectable Dosage Forms
The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
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Mitigating Risk Of Validated Analytical Procedure Failures When Upgrading Or Replacing LC Assets
Principles like instrument Quality by Design (iQbD) can help one understand the risks of validated analytical procedure performance when older workhorse LC instruments are replaced with newer instruments.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- How Service Providers Can Create Momentum In An Established Brand
- Advanced, Flexible Packaging Solutions To Meet Parenteral Product Demand
- Tuning Intermediate Volumes On Sepax™ C-Pro Cell Processing System
- Accelerating Drug Product Development From Early Phase To Scale Up And Commercialization
- Finding Impurities And Controlling Formations At Release

CONTENT COLLECTIONS

In this latest collection of interviews, CEOs share their views on the current thinking, strategies, and trends in the cell-therapy space regarding outsourcing, and working with external partners.
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